Slack Technologies sold for $27.7 billion

Salesforce acquires Slack in cash and stock deal worth $27.7B

Salesforce (CRM) and Slack Technologies (WORK) have entered into a definitive agreement under which Salesforce will acquire Slack.

Under the terms of the agreement, Slack shareholders will receive $26.79 in cash and 0.0776 shares of Salesforce common stock for each Slack share, representing an enterprise value of approximately $27.7 billion based on the closing price of Salesforce’s common stock on November 30.

The boards of each of Salesforce and Slack have approved the transaction and the Slack board recommends that Slack stockholders approve the transaction and adopt the merger agreement.

The transaction is anticipated to close in the second quarter of Salesforce’s fiscal year 2022.

Salesforce goes shopping

Salesforce has also entered into a voting agreement with certain stockholders of Slack common stock, under which each such stockholder has agreed to vote all of their Slack shares in favor of the transaction at the special meeting of Slack stockholders to be held in connection with the transaction, subject to certain terms and conditions.

The Slack shares subject to the agreement represent approximately 55% of the current outstanding voting power of the Slack common stock.

Salesforce expects to fund the cash portion of the transaction consideration with a combination of new debt and cash on Salesforce’s balance sheet.

One year chart of Slack Tech. stock price

Salesforce has obtained a commitment from Citigroup, Bank of America, and JPMorgan Chase for a $10B senior unsecured 364-day bridge loan facility.

Salesforce said, “Slack will be deeply integrated into every Salesforce Cloud.

Five year chart of Salesforce stock price

As the new interface for Salesforce Customer 360, Slack will transform how people communicate, collaborate and take action on customer information across Salesforce as well as information from all of their other business apps and systems to be more productive, make smarter, faster decisions and create connected customer experiences.”

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Sage Therapeutics shares jump on it depression drug

Sage Therapeutics, Biogen announce collaboration on SAGE-217, SAGE-324

Biogen (BIIB) and Sage Therapeutics (SAGE) announced that they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone for major depressive disorder, postpartum depression and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders.

Sage receives a large investment from Biogen

Zuranolone, a potential first-in-class, two-week, once-daily oral therapy in development for the treatment of MDD and PPD, is currently in Phase 3 development as part of the LANDSCAPE and NEST clinical programs.

Zuranolone has breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for MDD and, if successfully developed and approved, has the potential to be a novel treatment paradigm in depression.

Biogen gambles on Sage’s depression drug

The vision for zuranolone in MDD and PPD is based on its potential, being evaluated in the LANDSCAPE and NEST development programs, to work rapidly and to continue providing sustained benefit beyond the period of dosing.

Together, these two features, if supported by positive clinical efficacy and safety data, could provide an alternative option to how depression is treated today based on a target profile of an “as-needed” short course of treatment for a depressive episode, with rapid and sustained efficacy and favorable tolerability.

The development of an “as-needed” treatment for depression may help ease the difficulties associated with chronic use of antidepressants and may enhance quality of life and patient adherence.

To date, two positive pivotal studies have been completed with zuranolone 30 mg, one in MDD (MDD-201) and one in PPD.

Additionally, while the Phase 3 MOUNTAIN Study of zuranolone in MDD did not meet its primary endpoint, the encouraging data from the recently announced MOUNTAIN six-month follow-up period and the topline interim SHORELINE Study analysis, suggest the potential for zuranolone, if successfully developed and approved, to be uniquely positioned as a disruptive, distinct and novel treatment approach for patients.

Biogen and Sage believe that zuranolone is clinically active in MDD based on the data compiled to date and look forward to planned data readouts in 2021.

Sage is pursuing three development pathways for zuranolone in the U.S.: PPD; acute rapid response therapy in MDD when co-initiated with new standard antidepressant therapy; and “as-needed,” or episodic, treatment of MDD.

As a result, Sage is advancing four additional pivotal studies evaluating a 50 mg dose of zuranolone: a Phase 3 study in PPD, a Phase 3 study of use as an acute RRT in patients with MDD when co-initiated with new standard antidepressant therapy , a Phase 3 study in the acute treatment of MDD and an open label Phase 3 study evaluating the long-term safety, tolerability and efficacy of “as-needed” repeat treatment. Data from these studies are expected in 2021.

Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for zuranolone.

Beyond PPD and MDD, zuranolone may also have potential in other psychiatric disorders including bipolar disorder and generalized anxiety disorder. SAGE-324 is a next-generation positive allosteric modulator of GABAA receptors in Phase 2 development for essential tremor with potential in other neurological conditions such as epilepsy and PD.

Essential tremor is one of the most common movement disorders estimated to affect over six million patients in the U.S., and current standard of care may be inadequate for many.

Following encouraging results from a Phase 1 open-label study in essential tremor, Sage advanced SAGE-324 to the Phase 2a KINETIC Study, which Sage is currently conducting.

The KINETIC Study is a 28-day placebo-controlled study in patients with essential tremor expected to read out in 2021.

Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for SAGE-324 in essential tremor and, as appropriate, for potential expansion into other neurological disorders.

The strategic collaboration is global in scope and under the terms of the agreement, Sage will receive $1.525 billion in cash to be comprised of an upfront payment of $875 million and a $650 million equity investment in Sage from the purchase of approximately 6.2 million newly issued shares of Sage common stock at a price of $104.14 per share, representing a premium of 40 percent over the 30-day volume-weighted average share price of $74.39 per share as of November 25, 2020.

Should the zuranolone and SAGE-324 programs achieve certain development and commercial milestones, Sage will be eligible to receive up to approximately $1.6 billion in potential milestone payments. Biogen and Sage will share responsibility and costs for development as well as profits and losses for commercialization in the U.S.. Outside the U.S., Biogen will be responsible for development and commercialization, excluding Japan, Taiwan and South Korea with respect to zuranolone, and will pay Sage tiered royalties in the high teens to low twenties. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. The transaction is expected to close by the end of January 2021.

BIIB last traded at $241.75. SAGE last traded at $84.00.

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Xilinx sold for $35 billion

Xilinx to be acquired by AMD for $35B in all-stock transaction

AMD (AMD) and Xilinx (XLNX) announced they have entered into a definitive agreement for AMD to acquire Xilinx in an all-stock transaction valued at $35B.

Under the terms of the agreement, Xilinx stockholders will receive a fixed exchange ratio of 1.7234 shares of AMD common stock for each share of Xilinx common stock they hold at the closing of the transaction.

Xilinx makes programmable logic devices

Based on the exchange ratio, this represents approximately $143 per share of Xilinx common stock. Post-closing, current AMD stockholders will own approximately 74% of the combined company on a fully diluted basis, while Xilinx stockholders will own approximately 26%.

The transaction is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.

AMD expects to achieve operational efficiencies of approximately $300 million within 18 months of closing the transaction, primarily based on synergies in costs of goods sold, shared infrastructure and through streamlining common areas.

AMD goes shopping taking advantage of Intel’s troubles

The transaction has been unanimously approved by the AMD and Xilinx Boards of Directors.

The acquisition is subject to approval by AMD and Xilinx shareholders, certain regulatory approvals and other customary closing conditions.

The transaction is currently expected to close by the end of calendar year 2021.

Until close, the parties remain separate, independent companies. Dr. Lisa Su will lead the combined company as CEO. Xilinx President and CEO, Victor Peng, will join AMD as president responsible for the Xilinx business and strategic growth initiatives, effective upon closing of the transaction.

In addition, at least two Xilinx directors will join the AMD Board of Directors upon closing.

Xilinx, Inc. designs and develops programmable devices and associated technologies worldwide. The company offers integrated circuits (ICs) in the form of programmable logic devices (PLDs), such as programmable system on chips, and three dimensional ICs; adaptive compute acceleration platform; software design tools to program the PLDs; software development environments and embedded platforms; targeted reference designs; printed circuit boards; and intellectual property (IP) core licenses covering Ethernet, memory controllers, Interlaken, and peripheral component interconnect express interfaces, as well as domain-specific IP in the areas of embedded, digital signal processing and connectivity, and market-specific IP cores. XLNX closed at $114.55.

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Fulgent Genetics shares soar on Covid-19 testing

Fulgent Genetics surges after ‘record’ Q2 results

Shares of Fulgent Genetics (FLGT) have surged during Wednesday’s session after the company reported second quarter results after the market close last night.

The company noted that it had “record” figures for quarterly revenue, billable tests, adjusted earnings, and adjusted EBITDA, as it has commercially launched several tests for COVID-19 since March 2020.

EARNINGS

In its latest report, Fulgent Genetics reported Q2 adjusted EPS of 17c on revenue of $17.3M, compared to analysts’ estimates of (5c) and $10.05M.

The company delivered 180,513 billable tests in the quarter, an increase of 1003% year-over-year, and gross margin for the quarter improved roughly eight percentage points from the previous quarter and roughly 81% year-over-year.

Commenting on the results, chairman and CEO Ming Hsieh said, “The global COVID-19 pandemic has tested who we are as a company, and now more than ever we have demonstrated that Fulgent is a technology company with a proprietary platform built for massive scale.

Our technology is the cornerstone for all facets of our business, including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated lab services.

Covid-19 Test Kit

Our second quarter results illustrate how we quickly applied our technology to the needs of today, organically developing and launching multiple tests to detect COVID-19 with Emergency Use Authorization from the FDA, including an at-home test offered through Picture Genetics, our patient-initiated product.

These offerings have attracted major new customer accounts, resulting in an inflection point in our business and outlook.”

GUIDANCE:

On Fulgent’s quarterly conference call, CFO Paul Kim said that based on the “explosive” demand the company is seeing from the market and the quality of its customers, he continues to see the upward trajectory and transformation of the business continuing for the balance of 2020.

Fulgent now projects test volumes for 2020 to be over 1.3M, which translates to into over $120M in revenues. Kim added that he sees adjusted net income of $25M, or about $1.00 per share in FY20.

Analysts had expected the company to report FY20 EPS of 12c on revenue of $45.02M.

Analysts Comments:

Following the results, Piper Sandler analyst Steven Mah maintained an Overweight rating on Fulgent Genetics and raised his price target on the stock to $68 from $31.

Mah, who continues to believe COVID-19 testing is durable for the coming years, said he is encouraged by Fulgent’s early success in test volume, adding that his higher revenue estimates are due to increased COVID-19 expectations.

PRICE ACTION:

In afternoon trading, Fulgent Genetics shares are up nearly 23%, trading at $36.46.

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Sangamo signs deal with Novartis, shares jump

Sangamo executes global licensing agreement with Novartis for genomic medicines

Sangamo (SGMO) announced that it has executed a global licensing collaboration agreement with Novartis (NVS) to develop and commercialize gene regulation therapies to address three neurodevelopmental targets, including autism spectrum disorder, or ASD, and other neurodevelopmental disorders.

Sangamo signs distribution agreement with Novartis

The collaboration will leverage Sangamo’s propriety genome regulation technology, zinc finger protein transcription factors, or ZFP-TFs, to aim to upregulate the expression of key genes involved in neurodevelopmental disorders.

Zinc-finger protein transcription factors (ZFP TFs) can be designed to control the expression of any desired target gene, and thus provide potential therapeutic tools for the study and treatment of disease. 

Novartis receives positive CHMP opinion for Kymriah, Stockwinners
Novartis to use Sangamo to expand its markets

The collaboration will leverage ZFP-TFs engineered by Sangamo scientists in an effort to upregulate, or activate, the expression of genes that are inadequately expressed in individuals with certain types of neurodevelopmental disorders.

Under the terms of the agreement, over a three-year collaboration period, Novartis has exclusive rights to ZFP-TFs targeted to three undisclosed genes which are associated with neurodevelopmental disorders, including ASD and intellectual disability.

Novartis also has the option to license Sangamo’s proprietary AAVs.

Sangamo’s proprietary AAVs

Sangamo is responsible for certain research and associated manufacturing activities, all of which will be funded by Novartis, and Novartis assumes responsibility for additional research activities, investigational new drug-enabling studies, clinical development, related regulatory interactions, manufacturing and global commercialization.

Under the collaboration agreement, Novartis will pay Sangamo a $75 million upfront license fee payment within thirty days.

In addition, Sangamo is eligible to earn up to $720 million in other development and commercial milestone payments, including up to $420 million in development milestones and up to $300 million in commercial milestones.

Sangamo is also eligible to receive from Novartis tiered high single-digit to sub-teen double-digit royalties on potential net commercial sales of products arising from the collaboration.

SGMO is up 15% to $11.40. NVS is down 22 cents to $84.19.

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Pfizer and BioNTech report promising data on Covid-19 vaccine

Pfizer, BioNTech announce early data from Phase 1/2 study of vaccine candidate

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced preliminary U.S. data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic.

The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen.

Pfizer reports preliminary positive data

The manuscript describing the preliminary clinical data for the nucleoside-modified messenger RNA candidate, BNT162b1, which encodes an optimized SARS-CoV-2 receptor binding domain antigen, is available and is concurrently undergoing scientific peer-review for potential publication.

Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.

The ongoing U.S. Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1. The initial part of the study included 45 healthy adults 18 to 55 years of age.

Preliminary data for BNT162b1 was evaluated for 24 subjects who received two injections of 10 microgram and 30 microgram, 12 subjects who received a single injection of 100 microgram, and 9 subjects who received 2 doses of placebo control.

The participants received two doses, 21 days apart, of placebo, 10 microgram or 30 microgram of BNT162b1, or received a single dose of 100 microgram of the vaccine candidate.

Because of a strong vaccine booster effect, the highest neutralizing titers were observed seven days after the second dose of 10 microgram or 30 microgram on day 28 after vaccination.

The neutralizing GMTs were 168 and 267 for the 10 microgram and 30 microgram dose levels, respectively, corresponding to 1.8- and 2.8-times the neutralizing GMT of 94 observed in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

In all 24 subjects who received 2 vaccinations at 10 microgram and 30 microgram dose levels of BNT162b1, elevation of RBD-binding IgG concentrations was observed after the second injection with respective GMCs of 4,813 units/ml and 27,872 units/ml at day 28, seven days after immunization.

These concentrations are 8- and 46.3-times the GMC of 602 units/ml in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

At day 21 after a single injection, the 12 subjects who received 100 microgram of BNT162b1 had an RBD-binding IgG GMC of 1,778 units/ml and a SARS-CoV neutralizing GMT of 33, which are 3-times and 0.35-times, respectively, the GMC and GMT of the convalescent serum panel.

At the 10 microgram or 30 microgram dose levels, adverse reactions, including low grade fever, were more common after the second dose than the first dose.

Following dose 2, 8.3% of participants who received 10 microgram and 75.0% of participants who received 30 microgram BNT162b1 reported fever greater than or equal to 38.0 degrees C.

Local reactions and systemic events after injection with 10 microgram and 30 microgram of BNT162b1 were dose-dependent, generally mild to moderate, and transient.

The most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 microgram dose, which was severe. No serious adverse events were reported.

Given higher numbers of subjects experiencing local reactions and systemic events after a single 100 microgram dose with no significant increases in immunogenicity compared to the 30 microgram dose level, the 12 participants in the 100 microgram group were not administered a second dose.

These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial.

That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.

The preliminary clinical data from this ongoing study has been submitted for potential publication in a peer-reviewed journal and is available on an online preprint manuscript server.

The BNT162b1 candidate remains under clinical study and is not currently approved for distribution anywhere in the world. If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

In that event, BioNTech and Pfizer would work jointly to distribute the potential COVID-19 vaccine worldwide.

The Canadian company provides lipid nanoparticles or the formulation of various mRNA vaccines.

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American Airlines raises money!

American to sell more than $1.5B in shares, borrows $500M

American Airlines (AAL) announced proposed underwritten public offerings of $750,000,000 of shares of its common stock and $750,000,000 aggregate principal amount of its convertible senior notes due 2025.

The company intends to grant the underwriters of the offerings a 30-day option to purchase, in whole or in part, up to $112,500,000 of additional shares of Common Stock in the Common Stock Offering and a 30-day option to purchase, in whole or in part, up to $112,500,000 aggregate principal amount of additional Convertible Notes in the Convertible Notes Offering, in each case solely to cover over-allotments, if any.

The company expects to use the net proceeds from the Common Stock Offering and the Convertible Notes Offering for general corporate purposes and to enhance the company’s liquidity position.

The company also announced it intends to enter into a new $500M Term Loan B Facility due 2024 concurrently with the closing of the offering of the Notes.

12-Month chart of American Airlines stock

The company expects to use a portion of the net proceeds from the offering of the Notes and borrowings under the Term Loan to refinance its delayed draw term loan facility which the company and the Guarantor entered into on March 18, 2020 and is scheduled to mature on March 17, 2021, with the remainder for general corporate purposes and to enhance the company’s liquidity position.

AAL closed at $16.00.

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Watch shares of Alnylam Pharmaceuticals

Alnylam presents Phase 3 results from ILLUMINATE-A study of Lumasiran

Alnylam Pharmaceuticals (ALNY) announced Phase 3 results from the ILLUMINATE-A study of lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 – the gene encoding glycolate oxidase – in development for the treatment of primary hyperoxaluria type 1.

The clinical data were presented at a late-breaking session at the European Renal Association-European Dialysis and Transplant Association International Congress being held as a virtual event on June 6-9.

Lumasiran achieved the ILLUMINATE-A primary endpoint with a 53.5% mean reduction in urinary oxalate relative to placebo and showed a 65.4% mean reduction in urinary oxalate relative to baseline.

All tested study secondary endpoints were met, including the proportion of patients achieving near-normalization or normalization of urinary oxalate, compared with zero percent in the placebo group.

Lumasiran administration was associated with an encouraging safety and tolerability profile, with no serious or severe adverse events and with mild injection site reactions as the most common drug-related AE.

Primary hyperoxaluria (PH) constitutes a group of rare inherited disorders of the liver characterized by the overproduction of oxalate, an end-product of metabolism. High levels of oxalate are toxic because oxalate cannot be broken down by the human body and accumulates in the kidneys.

PH1 is an ultra-rare orphan disease caused by excessive oxalate production, and elevated urinary oxalate levels are associated with progression to end-stage kidney disease and other systemic complications.

Based on the ILLUMINATE-A results, Alnylam filed a New Drug Application with the U.S. Food and Drug Administration.

The FDA has granted a Priority Review for the NDA and has set an action date of December 3, 2020 under the Prescription Drug User Fee Act.

In addition, the Marketing Authorisation Application for lumasiran has been submitted to and validated by the European Medicines Agency, and has received Accelerated Assessment designation.

Stifel

Stifel analyst Paul Matteis believes full Alnylam’s Lumasiran data presented at ERA-EDTA reflect a relatively derisked clinical profile that’s very likely to attain regulatory approval.

Lumasiran treatment led to robust and durable reductions in urinary oxalate, which based on the well described biology in PH1 should ultimately lead to clinical benefit on renal outcomes, he contends.

The analyst notes that for the stock, lumasiran is already mostly priced-in here, though there’s some investment debate surrounding the market opportunity which is generally perceived to be ultra-orphan/small.

While he is also somewhat conservative in how he models revenues for lumasiran, there could be upside to numbers should approval/launch increase the PH1 diagnosis rate. Matteis has a Buy rating and a $159 price target on the shares.

ALNY closed at $127.59.

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White House selects vaccine finalists

Novavax sinks after White House omits as COVID vaccine finalist

The New York Times reports that Moderna (MRNA) is among the five finalists selected by the Trump administration as the most likely to produce a vaccine for the coronavirus.

Moderna (MRNA) is one of the finalists

By narrowing the field, the White House is betting it can identify the most promising vaccines at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in large quanities, the Times said.

Pfizer is also one of the finalists

The announcement of the decision will be made at the White House in the next few weeks, government officials said.

see Stockwinners.com
AstraZeneca is one of the five companies.

Dr. Anthony S. Fauci, the federal government’s top epidemiologist and director of the National Institute of Allergy and Infectious Diseases, hinted at the coming action on Tuesday when he told a medical seminar that “by the beginning of 2021 we hope to have a couple of hundred million doses.”

https://stockwinners.com/blog
Johnson & Johnson is also a finalist for Covid 19 vaccine

Finalists

A White House announcement is expected in the new few weeks. In addition to Moderna, the winners are AstraZeneca (AZN), Johnson & Johnson (JNJ), Merck (MRK) and Pfizer (PFE), according the Times.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
Merck is the final company on the list.

B. Riley FBR

B. Riley FBR analyst Mayank Mamtani views the selloff today in shares of Novavax on the New York Times report that the company was not selected as a finalist for the White House’s “Operation Warp Speed” as overdone.

Mamtani reiterates a Buy rating on Novavax. NVAX closed down 11% to $44.25.

Novax did not make the final cut, shares tumble

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Boeing fires 6,770 U.S. workers

Boeing starts involuntary layoffs with 6,770 U.S. workers losing jobs

Boeing (BA) President and CEO Dave Calhoun issued a letter to employees today providing an update on workforce actions, which stated in part, “Following the reduction-in-force announcement we made last month, we have concluded our voluntary layoff program.

And now we have come to the unfortunate moment of having to start involuntary layoffs. We’re notifying the first 6,770 of our U.S. team members this week that they will be affected.

Boeing beings involuntary layoffs

We will provide all the support we can to those of you impacted by the ILOs – including severance pay, COBRA health care coverage for U.S. employees and career transition services.

Covid19 related layoffs are adding up

Our international locations also are working through workforce reductions that will be communicated locally on their own timelines in accordance with local laws and benefit terms.

Boeing plans to cut 10% of it’s workforce

The COVID-19 pandemic’s devastating impact on the airline industry means a deep cut in the number of commercial jets and services our customers will need over the next few years, which in turn means fewer jobs on our lines and in our offices.

We have done our very best to project the needs of our commercial airline customers over the next several years as they begin their path to recovery. I wish there were some other way.”

Green Shoots

In another announcement, Dave Calhoun stated “We are seeing some green shoots. Some of our customers are reporting that reservations are outpacing cancellations on their flights for the first time since the pandemic started. Some countries and U.S. states are starting cautiously to open their economies again.

And some parts of our business, most notably on the defense side, will continue hiring to meet customer commitments and fill critical skill positions.

Boeing CEO Dave Calhoun

The Defense, Space & Security and defense services teams have achieved a number of milestones recently, including the successful return to orbit of the reusable and autonomous X-37B Orbital Test Vehicle.

We’re moving forward with our plan to restart 737 MAX production in Renton, Washington, as our return-to-service efforts continue.

And our Global Services team is changing its organization to ensure it is lean and focused on the post-COVID needs of its customers. But these signs of eventual recovery do not mean the global health and economic crisis is over. Our industry will come back, but it will take some years to return to what it was just two months ago.”

Company executives said last month that Boeing planned to cut about 10% of its global workforce this year as it reduces jetliner production, and union officials say the initial wave of layoffs was focused on Boeing’s Seattle-area commercial airplanes operation.

BA last traded at $146.47, up 1.2%.

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Inovio Shares Jump on COVID-19 Data

Inovio’s COVID-19 vaccine INO-4800 generates antibodies and immune responses

Inovio (INO) announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating “robust” neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2.

Inovio reports promising data, Stockwinners

The study was published in the peer-reviewed journal Nature Communications by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. Kate Broderick, Inovio’s Senior VP of R&D and Team Lead for COVID-19 vaccine development, said, “These positive preclinical results from our COVID-19 DNA vaccine not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700.

Inovio hopes its work would lead to a vaccine, Stockwinners

The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials.

” The studies demonstrated that vaccination with INO-4800 generated “robust” binding and neutralizing antibody as well as T cell responses in mice and guinea pigs.

The authors demonstrated virus neutralizing activity using three separate neutralization assays testing the vaccine’s ability to generate antibodies which can block virus infection.

Study authors also detected these antibodies in the lungs of the vaccinated animals which could be important in providing protection from SARS-CoV-2.

In addition, high levels of Spike-specific T cell responses were observed with INO-4800 vaccination, which could be important in mediating protection from the virus infection.

A Phase 2/3 efficacy trial is planned to start in July/August pending regulatory approval.

PIPER Comments:

Piper Sandler analyst Christopher Raymond noted that Inovio shares are up by a double digit percentage on the Nature Communications publication of preclinical data on the company’s CoV-19 DNA vaccine INO-4800, but he said “this isn’t new news.” The market currently has a “buy-first-ask-questions-later mentality on all things COVID,” but most of the data in this paper has been available since the pre-print in early March, said Raymond.

Additionally, while an ability to generate T-cell responses and functional neutralizing antibodies in mice and guinea pigs is important, the preclinical picture remains incomplete without non-human primate data and viral challenge data, which is needed to fully understand the potential, the analyst tells investors. Raymond, who thinks it is more prudent to reserve judgment until initial human data slated for the end of June is available, keeps a Neutral rating on Inovio shares.

INO closed at $14.50, last traded at $17.00

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Moderna shares jump on Fauci comments, possible COVID-19 vaccine

Moderna rises as Fauci comments on COVID vaccine potential highlighted

Shares of Moderna (MRNA) are trading higher, which is being attributed to comments made earlier this week by Dr. Anthony Fauci, the U.S. National Institute of Allergy and Infectious Diseases Director who has become one of the faces of the Trump administration’s COVID-19 response.

Fauci highlighted Moderna’s COVID-19 vaccine candidate, as well as another one in development at Oxford University, in an interview with National Geographic this week, telling the publication that he believes that the U.S. will have a vaccine ready for general use as soon as January “When we look at the immune response that you can induce with a modest dose – one that’s feasible to be translated into humans – and the amount of time it takes to get to that level of immunity, it is really quite impressive,” Fauci was quoted as saying when discussing both Moderna’s vaccine candidate and the one being developed at Oxford.

Modernal shares are higher on its vaccine potentail

“It is also really easy to scale up with these two, in the sense of making a lot of doses pretty quickly,” he reportedly added.

Dr. Fauci has been government’s leading Covid-19 expert

The interview, published two days ago, may be getting added attention after The Boston Business Journal published a recap with the headline “Fauci singles out Moderna’s coronavirus vaccine as reason for optimism” yesterday afternoon.

Moderna, Inc. (MRNA) is a clinical stage biotechnology company. It develops therapeutics and vaccines based on messenger RNA for the treatment of infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases.

Covid 19 has killed thousands of people worldwide

As of February 15, 2019 the company had 11 programs in clinical trials and a total of 20 development candidates in six modalities comprising prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics. Moderna, Inc. also has a collaboration with Lonza Ltd. for the manufacture of mRNA-1273, a COVID-19 vaccine.

MRNA is up 9.5% to $53.50.

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Morgan Stanley to acquire E-Trade for $58.74 per share

Morgan Stanley acquires E-Trade in all-stock deal valued at $13B

Morgan Stanley (MS) and E-Trade Financial (ETFC) have entered into a definitive agreement under which Morgan Stanley will acquire E-Trade in an all-stock transaction valued at approximately $13B.

Etrade sold for $13 B, Stockwinners

Under the terms of the agreement, E-Trade stockholders will receive 1.0432 Morgan Stanley shares for each E-Trade share, which represents per share consideration of $58.74 based on the closing price of Morgan Stanley.

The acquisition is subject to customary closing conditions, including regulatory approvals and approval by E-Trade shareholders, and is expected to close in the fourth quarter of 2020.

Morgan Stanley pays $13B for Etrade. Stockwinners

The transaction provides “significant upside potential” for shareholders of both Morgan Stanley and E-Trade, the company said in a statement.

“Shareholders from both companies will benefit from potential cost savings estimated at approximately $400 million from maximizing efficiencies of technology infrastructure, optimizing shared corporate services and combining the bank entities, as well as potential funding synergies of approximately $150 million from optimizing E-Trade’s approximate $56 billion of deposits,” they said.

Morgan Stanley said its “full-service, advisor-driven model coupled with E-Trade”s direct-to-consumer and digital capabilities, will allow the combined business to have best-in-class product and service offerings to support the full spectrum of wealth.”

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Watch Jazz Pharmaceuticals!

Jazz Pharmaceuticals receives EU Marketing Authorization for Sunosi

Jazz Pharmaceuticals (JAZZ) announced that the European Commission approved Sunosi to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure.

Jazz should be in play, Stockwinners

Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA.

Once-daily Sunosi is approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA.

Sunosi is approved in Europe, Stockwinners

At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for narcolepsy patients and both 75 mg and 150 mg doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through approximately nine hours post-dose.

The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.

The Marketing Authorization Application for Sunosi is based on data from four randomized placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness clinical trial program.

Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.

The Marketing Authorisation Application (MAA) for Sunosi is based on data from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial program. Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.

JAZZ closed at $151.05.

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ArQule sold for $2.7 billion

Merck to acquire ArQule for $20 per share

Merck (MRK) and ArQule (ARQL) announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7B.

Merck buys ArQule for $2.7B, Stockwinners

ArQule’s lead investigational candidate, ARQ 531, is a novel, oral Bruton’s tyrosine kinase, or BTK, inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies.

BTK inhibition has been shown to prevent B-cell receptor signaling that is critical for the survival and proliferation of leukemic cells in many B-cell malignancies.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
Merck buys ArQule, Stockwinners

ARQ 531 is a selective, reversible inhibitor that blocks both wild-type BTK and the C481S mutant form of the enzyme that is commonly associated with resistance to other BTK inhibitors.

In early clinical trials, ARQ 531 demonstrated a manageable safety profile and early signs of anti-tumor activity for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, and Richter’s Transformation.

ArQule lead investigative drug is ARQ531

Final data from the Phase 1 study of ARQ 531 will be presented on December 9 at the 61st American Society of Hematology, or ASH.

Under the terms of the acquisition agreement announced, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of ArQule.

The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of ArQule’s outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Upon the successful completion of the tender offer, Merck’s acquisition subsidiary will be merged into ArQule, and any remaining shares of common stock of ArQule will be canceled and converted into the right to receive the same $20 per share price payable in the tender offer.

The transaction is expected to close early in Q1 of 2020.

ARQL closed at $9.66, last traded at $19.90.

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